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Fertilization in VitroNCT03733912

Plasticizers and in Vitro Fertilization Outcomes

An observational study of Fertilization in Vitro, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the effect of Plasticizer metabolites concentration on the in vitro fertilization outcomes Read more about this study

Who is it for?
Ages 30 to 40 years, women only
Conditions the study is for
Fertilization in Vitro
What is being tested?
Phthalate metabolites measurement
How many people
80 participants
Where
1 siteTaiwan
Study dates
11 Jul 2018to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: This study was conducted in a medical center in southern Taiwan. 80 infertile female patients, aged 30 to 40 years old with normal ovarian function, receiving IVF treatment in the infertility outpatient were enrolled in this study. The participates were divided into two groups: successful pregnancy in the IVF cycle (n = 40) and non-pregnancy in the IVF cycle (n = 40). After getting the consent of the patients, we plan to do a questionnaire survey. Additionally, environmental dust and urine were sampled and analyzed the concentration of plasticizers metabolites.

Who may be able to join

  • Infertile women undergoing in vitro fertilization cycles
  • Normal ovarian reserve (AMH > 1.0 and AFC ≧ 5)

Who cannot join

  • Daily homestay time > 12 hrs
  • Diminished ovarian reserve (AMH ≦ 1.0 or AFC<5)
  • Oophorectomy
  • Gynecologic cancer patients
  • Severe male infertility

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

Other trials in Taiwan

About this study

Official title: To Investigate the Effect of Plasticizers on the Pregnancy in Vitro Fertilization Cycles

To investigate the effect of Plasticizer metabolites concentration on the in vitro fertilization outcomes

Read the detailed description

This study was conducted in a medical center in southern Taiwan. 80 infertile female patients, aged 30 to 40 years old with normal ovarian function, receiving IVF treatment in the infertility outpatient were enrolled in this study. The participates were divided into two groups: successful pregnancy in the IVF cycle (n = 40) and non-pregnancy in the IVF cycle (n = 40). After getting the consent of the patients, we plan to do a questionnaire survey. Additionally, environmental dust and urine were sampled and analyzed the concentration of plasticizers metabolites.The aim of this study is to investigate the effect of Plasticizer metabolites concentration on the in vitro fertilization outcomes.

Being tested
Phthalate metabolites measurement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phthalate metabolites measurementOther

    Also called diethylhexyl phthalate

    To measure phthalate metabolites of urine and house dust in Pregnancy and Non-pregnancy groups

Study groups in NCT03733912
Study groupRoleWhat they receive
PregnancyInfertile women undergoing in vitro fertilization cycle got pregnancy successfully. The pregnancy persisted over 12 weeks.
Receives: Other: Phthalate metabolites measurement
Non-pregnancyInfertile women undergoing in vitro fertilization cycle failed to reach pregnancy.
Receives: Other: Phthalate metabolites measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phthalate of urine

    Phthalate metabolites concentrations

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)

  1. Phthalate of environmental dust

    Phthalate metabolites concentrations

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start11 Jul 2018
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03733912
Sponsor's protocol ID
VGHKS18-CT3-09
Status last verified
Feb 2021
First submitted
6 Nov 2018
Last updated
18 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Messerlian C, Souter I, Gaskins AJ, Williams PL, Ford JB, Chiu YH, Calafat AM, Hauser R; Earth Study Team. Urinary phthalate metabolites and ovarian reserve among women seeking infertility care. Hum Reprod. 2016 Jan;31(1):75-83. doi: 10.1093/humrep/dev292. Epub 2015 Nov 15.

    PubMed 26573529

  • Chen ML, Chen JS, Tang CL, Mao IF. The internal exposure of Taiwanese to phthalate--an evidence of intensive use of plastic materials. Environ Int. 2008 Jan;34(1):79-85. doi: 10.1016/j.envint.2007.07.004. Epub 2007 Aug 31.

    PubMed 17765308

  • Jurewicz J, Hanke W. Exposure to phthalates: reproductive outcome and children health. A review of epidemiological studies. Int J Occup Med Environ Health. 2011 Jun;24(2):115-41. doi: 10.2478/s13382-011-0022-2. Epub 2011 May 19.

    PubMed 21594692

  • Koch HM, Lorber M, Christensen KL, Palmke C, Koslitz S, Bruning T. Identifying sources of phthalate exposure with human biomonitoring: results of a 48h fasting study with urine collection and personal activity patterns. Int J Hyg Environ Health. 2013 Nov;216(6):672-81. doi: 10.1016/j.ijheh.2012.12.002. Epub 2013 Jan 18.

    PubMed 23333758

  • Shea KM; American Academy of Pediatrics Committee on Environmental Health. Pediatric exposure and potential toxicity of phthalate plasticizers. Pediatrics. 2003 Jun;111(6 Pt 1):1467-74. doi: 10.1542/peds.111.6.1467.

    PubMed 12777573

  • Becker K, Seiwert M, Angerer J, Heger W, Koch HM, Nagorka R, Rosskamp E, Schluter C, Seifert B, Ullrich D. DEHP metabolites in urine of children and DEHP in house dust. Int J Hyg Environ Health. 2004 Oct;207(5):409-17. doi: 10.1078/1438-4639-00309.

    PubMed 15575555

  • Du YY, Guo N, Wang YX, Hua X, Deng TR, Teng XM, Yao YC, Li YF. Urinary phthalate metabolites in relation to serum anti-Mullerian hormone and inhibin B levels among women from a fertility center: a retrospective analysis. Reprod Health. 2018 Feb 23;15(1):33. doi: 10.1186/s12978-018-0469-8.

    PubMed 29471860

  • Wu H, Ashcraft L, Whitcomb BW, Rahil T, Tougias E, Sites CK, Pilsner JR. Parental contributions to early embryo development: influences of urinary phthalate and phthalate alternatives among couples undergoing IVF treatment. Hum Reprod. 2017 Jan;32(1):65-75. doi: 10.1093/humrep/dew301. Epub 2016 Dec 7.

    PubMed 27927842

  • Vabre P, Gatimel N, Moreau J, Gayrard V, Picard-Hagen N, Parinaud J, Leandri RD. Environmental pollutants, a possible etiology for premature ovarian insufficiency: a narrative review of animal and human data. Environ Health. 2017 Apr 7;16(1):37. doi: 10.1186/s12940-017-0242-4.

    PubMed 28388912

  • Minguez-Alarcon L, Gaskins AJ. Female exposure to endocrine disrupting chemicals and fecundity: a review. Curr Opin Obstet Gynecol. 2017 Aug;29(4):202-211. doi: 10.1097/GCO.0000000000000373.

    PubMed 28557831

  • Richardson MC, Guo M, Fauser BC, Macklon NS. Environmental and developmental origins of ovarian reserve. Hum Reprod Update. 2014 May-Jun;20(3):353-69. doi: 10.1093/humupd/dmt057. Epub 2013 Nov 27.

    PubMed 24287894

  • Hauser R, Gaskins AJ, Souter I, Smith KW, Dodge LE, Ehrlich S, Meeker JD, Calafat AM, Williams PL; EARTH Study Team. Urinary Phthalate Metabolite Concentrations and Reproductive Outcomes among Women Undergoing in Vitro Fertilization: Results from the EARTH Study. Environ Health Perspect. 2016 Jun;124(6):831-9. doi: 10.1289/ehp.1509760. Epub 2015 Nov 6.

    PubMed 26545148

  • Wu H, Olmsted A, Cantonwine DE, Shahsavari S, Rahil T, Sites C, Pilsner JR. Urinary phthalate and phthalate alternative metabolites and isoprostane among couples undergoing fertility treatment. Environ Res. 2017 Feb;153:1-7. doi: 10.1016/j.envres.2016.11.003. Epub 2016 Nov 19.

    PubMed 27875712

Questions about this trial

What is this clinical trial studying?

An observational study of Fertilization in Vitro, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phthalate of urine (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03733912, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.

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